Devices

DeRoyal Sterile Custom kits

  • Model / Serial
    a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the states of GA, IN, FL, and PA
  • Product Description
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: || a) Incision and Drainage Tray, REF 47-763.04 || b) Incision and Drainage Tray, REF 47-763.06 || c) Incision and Drainage Tray, REF 47-763.07 || d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 || e) Incision and Drainage Tray, REF 89-6818.02 || f) Plastic Pack, REF 89-7212.04 || g) Plastic Pack, REF 89-7212.05 || Product Usage: || Custom surgical and procedural kits
  • Manufacturer
    DeRoyal Industries Inc
  • 1 Event

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall DeRoyal Sterile Custom kits
  • Model / Serial
    (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to states of: CA and MO.
  • Product Description
    DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical
  • Manufacturer
    DeRoyal Industries Inc